The Chennai-based pharma major Orchid Chemicals & Pharmaceuticals Ltd has successfully completed the 'limited proof-of-concept Phase 2(a) clinical trials' of an anti-diabetic molecule (BLX-1002) in Europe.
Orchid has been working on this molecule in association with its US JV partner, Bexel Pharmaceuticals Inc. The result is a major breakthrough for the company.
According to the company, "The ascending multiple-dose blinded placebo controlled safety and tolerability studies that were conducted on 24 Type-2 diabetic volunteers have shown promising results."
The tests provide evidence of the glucose lowering efficacy and the triglycerides lowering potential of the molecule in diabetic patients. No adverse impact or reactions were noticed during the tests in liver enzymes like AST and ALT. Another favourable result is that the molecule does not induce weight gain unlike other known anti-diabetic compounds.
BLX-1002 is a novel orally active anti-diabetic compound that has no affinity with PPAR (alpha or gamma) receptors. In contrast to all known PPAR agonist compounds, BLX-1002 showed no change in liver enzymes.
The company is satisfied that the patent application filed for this novel molecule (BLX-1002) in the US patent office has been granted, admitting all claims.
The patent covers the efficacy of the molecule, not only in diabetes and hyperlipidemia but also in certain other auto-immune and neurological indications.
Orchid has already started discussions with several multinational companies who have shown interest in the molecule. With the grant of the patent by the US patent office and the availability of Phase 2(a) results, Orchid anticipates an acceleration of the discussions.
"We are quite happy on the progress of this molecule and the promising results that have been recorded in the Phase 2(a) trials. It is noteworthy that in about 2 years of forming the joint venture with Bexel, we have been able to complete Phase 2(a) trials and bring a molecule to the out-licensing stage. We are hopeful that the results of the trials will help build a strong out-licensing deal," said K Raghavendra Rao, Managing Director, Orchid Chemicals & Pharmaceuticals Ltd.
"We believe that this should also strongly position Orchid in the global drug discovery space. Orchid has identified lead molecules in a few other therapeutic areas which are currently undergoing pre-clinical trials and we are confident of taking them into Phase 1 trials during this fiscal," said Rao.